PROphylaxis in NOn Major Orthopaedic Surgery

• Status: Terminated
• Trial end date: 2018-04-16
• Target enrollment: 0
• Participant gender: All

Summary

PRONOMOS is an international multicentre, interventional, parallel, randomised, double-blind non-inferiority study comparing rivaroxaban 10mg od to an active comparator, enoxaparin 4000 UI od in 4040 valid subjects requiring orthopaedic surgery (except low risk such material removal foot surgery or hallux valgus without patient risk factor [6], and major orthopaedic surgeries for femoral neck and trochanteric fractures, THR, TKR)

Pre-randomization treatment with LMWH anticoagulant is allowed for a maximum duration of 24 hours. However, only a single pre-randomization dose of LMWH is allowed. After randomization, patients allocated to the rivaroxaban arm will receive rivaroxaban 10 mg once-daily started 6-10 hours provided haemostasis has been established after surgery or 24h hours after LMWH injection if needed for the intended treatment duration of 2 to 12 weeks based on medical judgment (according to immobilization). Patients allocated to the comparator arm will receive enoxaparin once daily for the same intended treatment duration. All patients will have a 30-day observational period after cessation of treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborator: Bayer
• Treatments: Enoxaparin; Rivaroxaban

Criteria

Inclusion Criteria:

1. Signed and dated informed consent form,

2. Age ≥ 18 years,

3. Hospitalised for non-major orthopaedic surgery and requiring thromboprophylaxis according to the investigator's judgement on VTE risk such Achilles' repair, hip (except femoral neck and trochanteric fracture), knee, tibial plateau, femur (non femoral head), tibial and ankle fractures and tibial osteotomy, tibial transposition, arthrodesis of leg articulation, ligament repair of the knee or the ankle or any elective orthopaedic limb surgery requiring thromboprophylaxis).

Exclusion Criteria:

1. Major orthopaedic surgery Hip and Knee replacement, femoral neck and trochanteric fractures, spine surgery,

2. Low risk surgery without patient VTE risk: foot surgery (Hallux Valgus), material removal,

3. Delay between hospitalisation and randomisation greater than two days,

4. Women of childbearing potential not using a reliable contraceptive method throughout the study period (a list of reliable contraceptive methods is provided in the accompanying SPM),

5. Women pregnant or breast-feeding during the study period,

6. Body weight less than 50 kg (to avoid bleeding over risk) or over 120 kg,

7. Long term treatment with VKA therapy or NOAC,

8. Concomitant treatment with clopidogrel, prasugrel and ticagrelor,

9. Platelet count < 100 Giga/L,

10. Documented history of acquired or inherited bleeding disorder (e.g., von Willebrand's disease),

11. Severe renal failure with calculated creatinine clearance (Cockcroft Formula) < 30 mL/min,

12. Severe hepatic insufficiency with prothrombin time < 60% or liver impairment associated with coagulation disorders,

13. History of thrombocytopenia,

14. Any other current significant medical condition that might interfere with treatment evaluation according to the investigator's judgement,

15. Known hypersensitivity or other severe reaction to any component of the investigational medicinal product(s),

16. Participation in another clinical study involving an investigational medicinal product within 30 days prior to inclusion or concomitantly with this study,

17. Active bleeding or contraindication to anticoagulant therapy

18. Chronic alcoholic intoxication,

19. Anticipated poor compliance of subject with study procedures